D-MAPPS for Graft-versus-Host Disease

(oGVHD Trial)

Recruiting at 4 trial locations

Overseen By Marissa Harrell, Phd

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Regenerative Ocular Immunobiologics LLC

Must not be taking: Topical steroids, Tacrolimus, Tetracyclines, Antibiotics

Disqualifiers: Rheumatoid arthritis, Lupus, Scleroderma, others

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

Trial Summary

Do I have to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot have significant changes in your systemic immunosuppressive regimen within 2 weeks of starting the study, and you should not change the dosage of tetracycline compounds or the frequency of preserved anti-glaucoma medications close to the study start.

What data supports the effectiveness of the drug D-MAPPS™ Ophthalmic Solution for treating graft-versus-host disease?

Research shows that D-MAPPS™ Ophthalmic Solution can reduce inflammation and help repair eye tissues in conditions like dry eye disease, which suggests it might also help with eye problems in graft-versus-host disease. ^{1 2 3 4 5}

Is D-MAPPS safe for use in humans?

The research suggests that platelet-derived eye drops, which may be similar to D-MAPPS, are safe and well-tolerated for treating ocular graft-versus-host disease, with most patients experiencing benefits and no major safety concerns reported. ^{2 3 6 7 8}

What is the purpose of this trial?

A Double-Masked, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of d-MAPPS™ Ophthalmic Solution in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGHVD)

Eligibility Criteria

This trial is for individuals with chronic ocular Graft-Versus-Host Disease (oGVHD), a condition affecting the eyes after stem cell or bone marrow transplantation. Participants should not have high blood pressure to be eligible.

Inclusion Criteria

Minimum Oxford Schema grad of ≥ 1 in at least one eye

Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual

OSDI scored of ≥ 22

Exclusion Criteria

Significant change, as judged by the principal investigator, in systemic immunosuppressive regimen within 2 weeks of study entry

I have a cancer affecting my eye or nearby areas.

I haven't changed my tetracycline medication dose in the last month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive d-MAPPS™ or placebo, self-administered as 2 drops into each eye four times a day for 90 days

12 weeks

3 visits (in-person) at 30, 60, and 90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• D-MAPPS™ Ophthalmic Solution

Trial Overview The study tests D-MAPPS™ Ophthalmic Solution against a placebo to evaluate its safety, tolerability, and effectiveness in treating oGVHD. It's a double-masked trial, meaning neither the participants nor the investigators know who receives the real treatment or placebo.

Participant Groups

Group I: Both patient and PI are masked. Experimental Treatment 3 Interventions

Upon acceptance into the study, the sponsor will be notified, and the patient will be randomized to the treatment or placebo arm. Randomization Code Key will have limited access to only authorized personnel. Based on the results of the randomization selection, the sponsor will provide the appropriate subject number and lot coded eyedropper bottles containing d-MAPPS™ or Placebo/sterile water to the doctor for dissemination.

Group II: This arm randomizes the actual drug to the patient. Active Control 1 Intervention

Based on randomization, d-MAPPS™ will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.

Group III: This arm randomizes the placebo to the patient. Placebo Group 1 Intervention

Based on randomization Placebo/sterile water, will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.

Who Is Running the Clinical Trial?

Regenerative Ocular Immunobiologics LLC

Lead Sponsor

Trials

1

Recruited

1+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Therapeutic Potential of d-MAPPS™ for Ocular Inflammatory Diseases and Regeneration of Injured Corneal and Retinal Tissue. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Treatment of severe chronic ocular graft-versus-host disease using 100% autologous serum eye drops from a sealed manufacturing system: a retrospective cohort study. [2018]

3. Italy pubmed.ncbi.nlm.nih.gov

Predictive models for ocular chronic graft-versus-host disease diagnosis and disease activity in transplant clinical practice. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Plasma rich in growth factors for the treatment of dry eye from patients with graft versus host diseases. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Validation of measurement scales in ocular graft-versus-host disease. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A Single-Center Pilot Prospective Study of Topical Application of Platelet-Derived Eye Drops for Patients with Ocular Chronic Graft-versus-Host Disease. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Ophthalmic cyclosporine use in ocular GVHD. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Topical cyclosporine-A in dry eye associated with chronic graft versus host disease. [2013]